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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBoston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14603
PMA NumberP010062
Supplement NumberS014
Date Received11/22/2024
Decision Date02/20/2025
Product Code NUU 
Advisory Committee Ophthalmic
Clinical TrialsNCT05984290
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementing a design module of the existing software for generating lathe cutting files to provide alternative posterior lens designs for Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment
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